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Division 1 Precise identification of the product and of its active substance(s)

United Kingdom

Original text. Later amendments are not shown.

  • international non-proprietary name (INN),

  • International Union of Pure and Applied Chemistry Name (IUPAC),

  • Chemical Abstract Service (CAS) number,

  • therapeutic, pharmacological and chemical classification,

  • synonyms and abbreviations,

  • structural formula,

  • molecular formula,

  • molecular weight,

  • degree of impurity,

  • qualitative and quantitative composition of impurities,

  • description of physical properties,

  • melting point,

  • boiling point,

  • vapour pressure,

  • solubility in water and organic solvents expressed in g/l, with indication of temperature,

  • density,

  • spectra of refraction, rotation, etc.,

  • formulation of the product.

Notes on Annex II

Footnotes

f1

This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.